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Recall Observatory FDA recall evidence

Device product

Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)

Z-1813-2013

May 16, 2013

Class II

Product summary

Firm
HeartWare Inc
Event
Event 65328
Status
Terminated
Classification
Class II
Quantity
76 (US) and 82 (International)
Official record key
device-enforcement:Z-1813-2013

Official wording

Reason: Potential to electrostatic discharged (ESD)

Code information: US product: Model 1400, 1401US, 1403US, 1404 International: Model 1400, 1401XX, 1407XX, 1408 ALL HEARTWARE CONTROLLER SERIAL NUMBERS

Distribution pattern: Worldwide Distribution - USA including AL, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI. Internationally to: Australia, Austria, Belguim, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zeland,Norway, Poland Singapore, South Africa, Switzerland, Turkey, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential to electrostatic discharged (ESD)